Magnet-assisted device (Flexagon SFM plus OTOLoc) to join sections of the colon

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm early feasibility study testing the Flexagon 25mm Self Forming Magnet (SFM) system plus OTOLoc to create side-to-side ileo-colic, colo-colonic and side-to-side or end-to-side colorectal anastomoses. Up to 3 roll-in (training) participants may be enrolled at centers without prior SFM experience, and a primary analysis cohort will include at least 17 participants. The primary endpoint is a composite safety/effectiveness measure defined as successful creation of the target anastomosis without procedure-, device- or anastomosis-related reoperation through 30 days. All procedures are performed under general anesthesia by trained surgeons, with follow-up at discharge, day 7, day 30, and day 60.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 22 years or older at screening
2. Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent document
4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure
5. All cancer patients must have completed chemotherapy ≥1 months prior to procedure
6. Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study
7. Able to refrain from smoking during study follow-up period

Exclusion Criteria:

1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
2. BMI \> 55 kg/m2
3. Uncontrolled diabetes (defined as HbA1c \>10%)
4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
5. Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
7. History of recurrent small bowel obstructions.
8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
11. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
12. Congestive heart failure with ejection fraction \<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
13. Decompensated chronic obstructive lung disease
14. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
15. Contraindication to general anesthesia
16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
17. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
18. Contraindication to general anesthesia
19. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator

Where it's running

• Orlando Health
  Orlando, Florida, United States Recruiting
• University of Texas Health Science Center
  Houston, Texas, United States Not yet recruiting

Study contacts

• Study coordinator: Peter J Lukin, BS
• Email: peter.lukin@giwindows.com
• Phone: 9787610183

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.